Does dabigatran increase the rate of bleeding events compared to warfarin?
An FDA analysis of the Mini-Sentinel database demonstrated that real-world bleeding rates with dabigatran are not higher than those with warfarin.
Serious and fatal bleeding events associated with use of the anticoagulant dabigatran have been reported. The FDA used the Mini-Sentinel database to determine that the actual rates of bleeding events were not higher with dabigatran than with warfarin.
Southworth et al. (2013) studied this question.